Pilot Evaluation of a New Galyfilcon A Contact Lens Compared to a Marketed Galyfilcon A Contact Lens



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 39
Updated:6/21/2018
Start Date:February 1, 2010
End Date:April 1, 2010

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A Multi-site Dispensing Evaluation Comparing a New Galyfilcon A Prototype Lens With a Marketed Galyfilcon A Contact Lens

The purpose of this study is to compare lens surface characteristics and comfort between an
experimental contact lens and a marketed contact lens.


Inclusion Criteria:

- The subject must be at least 18 years of age and no more than 39 years of age.

- The subject is a current spherical soft contact lens wearer (defined as a minimum of 6
hours of daily wear (DW) for a minimum of 1 month prior to the study) and willing to
wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear
per day at least five days of the week) for the duration of the study.

- The subject's optimal vertexed spherical equivalent distance correction must be
between -1.00 and - 9.00D.

- Any cylinder power must be ≤ -0.75D.

- The subject must have visual acuity best correctable to 20/25+3 or better for each
eye.

- The subject must read and sign the Statement of Informed Consent.

- The subject must appear able and willing to adhere to the instructions set forth in
this clinical protocol.

Exclusion Criteria:

- Ocular or systemic allergies or disease which might interfere with contact lens wear.

- Systemic disease or use of medication which might interfere with contact lens wear.

- Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal
staining, or any other abnormalities of the cornea which would contraindicate contact
lens wear.

- Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which
might interfere with contact lens wear.

- Any ocular infection.

- Any corneal distortion resulting from previous hard or rigid gas permeable contact
lens wear.

- Pregnancy or lactation.

- Diabetes.

- Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease
(e.g. HIV).

- Habitual contact lens type is toric, multifocal, or is worn as extended wear.
We found this trial at
9
sites
6
mi
from 43215
Columbus, OH
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1078
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from 43215
Amarillo, TX
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2096
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from 43215
Cupertino, CA
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?
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from 43215
East Lansing, MI
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Huntington Beach, California 92646
1967
mi
from 43215
Huntington Beach, CA
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668
mi
from 43215
Jacksonville, FL
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1972
mi
from 43215
Los Angeles, CA
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792
mi
from 43215
Orlando, FL
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2071
mi
from 43215
Pismo Beach, CA
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